Saliva Direct COVID 19 Test

• What is the SalivaDirect Covid-19 Test?

This is a test that uses reagent developed by Yale University to help make COVID-19 PCR testing more accessible, comfortable and affordable.

• How accurate is the SalivaDirect Test?

100% Clinical Specificity and 94% Clinical Sensitivity

• What is the methodology for the SalivaDirect Test?

Real Time RT-PCR, DNA

• How long does it take to get the test results back?

Within 24hrs upon receiving

• Is this test authorized by the FDA?

Yes, under the Emergency Use Authorization (EUA).

• What is the difference between the SalivaDirect Real Time RT-PCR test and the swab Real Time RT-PCR test?

Saliva enables non-invasive sampling, and observed self-collection, instead of nasal/ nasopharyngeal swab, which may be uncomfortable, may cause irritation, and requires a trained health professional for collection. Also, native saliva is submitted, which negates the use of transport preservatives (potentially interfering with PCR detection) between collection and testing time. Saliva is a more consistent biological sample, as opposed to swabs, which may not always be collected consistently.

• Which proteins are being identified using the SalivaDirect method?

The assay targets a specific region of the SARS-CoV-2 nucleocapsid (N1) and a human RNaseP (RP) control in every sample. It is important that we, as providers, verify the human origin of all samples received by the presence of human DNA in the collected fluid.

• What is a false negative result?

The test can sometimes show a negative result even if you are infected SARS-CoV-2, the virus that causes COVID-19. This can happen if: It is too early in infection for the test to detect the virus. There was a problem with your sample or the test itself. A false negative result on this test may be more likely to occur if your sample was not shipped back to our lab the same day it was collected. If your results are negative and you’re having symptoms, continue to follow isolation precautions and ask your healthcare provider if you need further testing. If your results are negative and you don’t have any symptoms, continue to monitor for any symptoms up to 14 days after your last possible exposure.

• What is a false positive result?

This test can sometimes show a positive result even if you are not infected with SARS-CoV-2, the virus that causes COVID-19. This test has been designed to minimize false positive results but they can still happen due to problems with the sample that can occur during collection, transport, and/or testing.

• Will someone contact me about my results?

We will contact you with your results. Access will report COVID-19 test results to us along with appropriate public health agencies in accordance with applicable requirements.

• Where can I learn more about COVID-19?

Centers for Disease Control and Prevention: About Coronavirus Disease 2019 (COVID-19) World Health Organization: Coronavirus disease (COVID-19) outbreak